FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1993751
·
Received January 13, 2011
Report
- Report Number
- 3004209178-2011-00360
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 3, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A POWER-ON-RESET (POR) CONDITION WAS REPORTED WHILE THE PATIENT WAS RECHARGING THEIR NEUROSTIMULATOR. ADDITIONAL INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD063117N| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC014817N| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC013619N| EXPLANTED:| LEAD: MODEL 3487A, LOT# V047368| LEAD: MODEL 3487A, LOT# V017144| ACCESSORY: MODEL 37752, LOT# NKA035797N| EXPLANTED: |